Post-Approval Clinical Trial Support and Placebos

Research institutions embarking on the study of approved drugs can face a challenge when it comes to managing the drug and placebo supply process.

The dilemma: a drug’s original manufacturer has little incentive to manufacture visually identical placebos on the comparatively limited scale required by most clinical trials. However, many drugs — especially those in tablet form — are notoriously difficult to simulate as placebos. As an alternative, clinicians turn to compounding pharmacies to over-encapsulate active ingredient and placebo dosages. But over-encapsulation can affect absorption rates and possibly compromise a study’s reliability. Also, compounding pharmacies don’t always have the capacity, expertise, or regulatory licensing to source active ingredients, package and label dosages, and randomize samples in support of blinded studies.

Green Mountain Pharmaceuticals offers institutional researchers a turnkey solution for advanced clinical trials, allowing them to focus on conducting their study without the distraction of managing the supporting processes and activities related to the drug portion of the study. Our services include:

Active ingredient sourcing – We will procure the drug under study in the quantity you need from our network of wholesale suppliers.

Packaging and labeling – Green Mountain offers the packaging and labeling services you need to ensure compliance with your study guidelines and procedures.

Dispensing – We can deliver study medications in bulk to your institutional pharmacy or in packaged and labeled forms directly to you or your study subjects.

Randomized trial and blind study support – We offer the tracking and monitoring to support a fully randomized blind study.

A GMP-registered drug facility – Green Mountain complies with all the applicable cGMPs for drug manufacturing and distribution.

Green Mountain Pharmaceuticals has played an instrumental role in helping leading research institutions understand a drug’s efficacy in treating additional diagnoses and disease states and analyze interactions and synergistic possibilities. Contact us today to find out how we can support you in conducting a successful, empirically sound clinical trial.